A Phase 3 Randomized Trial of Chemotherapy With or Without Panitumumab in Patients with Metastatic and/or Recurrent Squamous Cell Carcinoma of the Head and Neck

Amgen Inc0 sites650 target enrollmentMarch 19, 2007

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Metastatic and/or Recurrent Squamous Cell Carcinoma of the Head and Neck
Sponsor: Amgen Inc
Enrollment: 650
Status: Active, not recruiting
Last Updated: 13 years ago

No summary available.

Registry

who.int

Start Date

March 19, 2007

End Date

TBD

Last Updated

13 years ago

Study Type

Interventional clinical trial of medicinal product

Sex

All

Sponsor

•Histologically or cytologically confirmed SCCHN or its variants (eg, basaloid squamous cell carcinoma and adenosquamous cell carcinoma) of the oral cavity, oropharynx, hypopharynx, or larynx
•Diagnosis of metastatic disease and/or recurrent disease following locoregional therapy and determined to be incurable by surgery or radiotherapy
•Subjects who have received radiation as primary therapy are eligible if locoregional
•recurrence is in the field of radiation and has occurred (greater than or equal to) 6 months after the completion of radiation therapy. Subjects whose locoregional recurrence is solely outside the field of radiation are eligible if the recurrence has occurred (greater than or equal to) 3 months after the completion of radiation therapy.
•Measurable or non\-measurable disease. Target lesions must not be chosen from a
•previously irradiated field unless there has been radiographically and/or pathologically documented tumor progression in that lesion prior to randomization.
•ECOG performance status of 0 or 1
•Man or woman (greater than or equal to) 18 years of age
•Hematological function, as follows ((less than or equal to) 10 days prior to randomization):
•Absolute neutrophil count (ANC) (greater than or equal to) 1\.5 x 109/L

•Documented or symptomatic central nervous system metastases
•History of another primary cancer, except:
•Curatively treated in situ cervical cancer, or
•Curatively resected non\-melanoma skin cancer, or
•Other primary solid tumor curatively treated with no known active disease
•present and no treatment administered for (greater than or equal to) 2 years prior to randomization
•Subjects whose only site of metastatic disease is a single spiculated lung nodule are assumed to have a second lung primary and are excluded unless there is unequivocal pathological confirmation of metastasis of the SCCHN primary
•Nasopharyngeal carcinoma
•Prior systemic treatment for metastatic and/or recurrent SCCHN
•Subjects with recurrent disease may have received re\-irradiation; however